FDA approves once-monthly Abilify for schizophrenia

February 28, 2013|Reuters

Feb 28 (Reuters) - U.S. regulators on Thursday approved aonce-monthly injectable form of Abilify, the blockbustertreatment for schizophrenia, which will be sold by Japanesedrugmaker Otsuka and Danish drug group Lundbeck.

In July 2012, the U.S. Food and Drug Administration declinedto approve the medicine, Abilify Maintena, citing deficienciesfrom an inspection of a third-party supplier of sterile water.Otsuka and Lundbeck resubmitted their marketing application soonafterward, after working with an alternative supplier.

About 1 percent of adults in the United States are believedto have schizophrenia, a disorder of thought processes that caninvolve hallucinations, delusions and poor emotionalresponsiveness.

The new formulation of Abilify is meant to provide long-termprevention of relapses from schizophrenia symptoms, particularlyfor patients who don't faithfully take their anti-psychosismedicines.

But the medicine has a convenience disadvantage. It comes ina "cake" form, which must be diluted with sterile water forinjection. That means it has to be given by a healthcareprofessional.

For a decade, Otsuka and Bristol-Myers Squibb hadco-marketed the once-daily basic formulation of Abilify, whichhad global sales of $2.8 billion in 2012. Under an updatedpartnership agreement, Otsuka early this year began to take oncomplete marketing responsibility for basic Abilify, butBristol-Myers will continue to manufacture the medicine andshare in revenue from it.